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Pyrazoloacridine in Treating Patients With Advanced Non-small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pyrazoloacridine
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed non small cell lung cancer ineligible for higher priority protocols Sputum cytology acceptable Stage IIIB/IV Must have measurable or evaluable disease Lesion outside prior radiotherapy fields Cytology-positive pleural effusion and ascites are neither measurable nor evaluable No brain metastases on CT PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 1.5 mg/dL Other: No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile patients Blood/body fluid analyses within 7 days prior to registration Imaging/exams for tumor measurement within 28 days prior to registration PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: One prior adjuvant or neoadjuvant chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy and recovered AND Progressive disease outside of radiation port Surgery: Recovered from any prior surgery

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pyrazoloacridine

Arm Description

Pyrazoloacridine 750 mg/m2 by 3 hour infusion, every 21 day s in the absence of progressive disease or prohibitive toxicity.

Outcomes

Primary Outcome Measures

Evaluate toxicity of pyrazoloacridine.

Secondary Outcome Measures

Evaluate the response frequency of pyrazoloacridine.

Full Information

First Posted
November 1, 1999
Last Updated
April 25, 2013
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002656
Brief Title
Pyrazoloacridine in Treating Patients With Advanced Non-small Cell Lung Cancer
Official Title
PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CARCINOMA
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 1995 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of chemotherapy with pyrazoloacridine in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Detailed Description
OBJECTIVES: I. Evaluate the antitumor activity of pyrazoloacridine (PZA) administered by 3-hour infusion to patients with advanced non small cell lung cancer (NSCLC). II. Determine the qualitative and quantitative toxicities of PZA administered on this schedule. III. Determine the response and survival durations of NSCLC patients treated with PZA. OUTLINE: Single-Agent Chemotherapy. Pyrazoloacridine, PZA, NSC-366140. PROJECTED ACCRUAL: If 2 or 3 responses are observed in the first 18 evaluable patients, 12 additional patients will be entered. Accrual is expected to take 5-12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pyrazoloacridine
Arm Type
Experimental
Arm Description
Pyrazoloacridine 750 mg/m2 by 3 hour infusion, every 21 day s in the absence of progressive disease or prohibitive toxicity.
Intervention Type
Drug
Intervention Name(s)
pyrazoloacridine
Intervention Description
Pyrazoloacridine 750 mg/m2 by 3 hour infusion, every 21 day s in the absence of progressive disease or prohibitive toxicity. Depending on the prior cycle toxicity the dose should be escalated, maintained or reduced, utilizing levels: -1, 0 (initial dose level), 1 - Level +1 (820mg/m2); Level 0 (750mg/m2); Level -1 (600mg/m2)
Primary Outcome Measure Information:
Title
Evaluate toxicity of pyrazoloacridine.
Time Frame
Weekly prior to each treatment cycle.
Secondary Outcome Measure Information:
Title
Evaluate the response frequency of pyrazoloacridine.
Time Frame
After 2 treatment cycles then every 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed non small cell lung cancer ineligible for higher priority protocols Sputum cytology acceptable Stage IIIB/IV Must have measurable or evaluable disease Lesion outside prior radiotherapy fields Cytology-positive pleural effusion and ascites are neither measurable nor evaluable No brain metastases on CT PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 1.5 mg/dL Other: No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile patients Blood/body fluid analyses within 7 days prior to registration Imaging/exams for tumor measurement within 28 days prior to registration PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: One prior adjuvant or neoadjuvant chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy and recovered AND Progressive disease outside of radiation port Surgery: Recovered from any prior surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoinette J. Wozniak, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

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Pyrazoloacridine in Treating Patients With Advanced Non-small Cell Lung Cancer

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